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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
November 2014
Big Changes in Australia for Devices
3 min reading time

Australia’s “Fast Track” process – whereby 90% of medical devices are approved based on their CE marking through an expedited process – has been open to importers for more than a decade.

Two weeks ago, a long campaign championed by Sydney-based regulatory affairs expert Arthur Brandwood came to fruition. The Australian Therapeutic Goods Administration (TGA) agreed to give domestic manufacturers the same access as importers.

Arthur will talk about the big changes in Australian for devices on a November 18 webinar: http://medgroup.biz/TGA-changes

He’ll also cover:
• Australia’s aggressive deregulatory agenda
• The Australian tax incentive (43.5% for R&D expenditure)
• The simple process for regulation of clinical trials in Australia
• TGA’s web based submission process for device approvals

So if you or members of your team do medical device business in Australia, join us on the call.

We’ll record it and make the replay, slides, and transcript available to all who register – even if you can’t make the live event.

That link again: http://medgroup.biz/TGA-changes

++++++++++

Arthur is among the presenters at The Asia-Pacific Summit for Medical Devices (March 5-6, San Diego).

See http://AsiaPacificDeviceSummit.com

Should you attend? Yes, if:
• You are considering marketing your device in the region
• You need help managing the infrastructure
• Your growth overseas is doing too well and you can’t control it

The event brings local experts from Taipei, Singapore, Jakarta, Sydney, Kuala Lumpur, and Beijing right to you in beautiful San Diego. To get this collective knowledge and these introductions, you’d otherwise have to fly to the Asia-Pacific yourself!

I’m going. See the agenda at http://AsiaPacificDeviceSummit.com

++++++++++

Discussions This Week

Is a Prototype Enough?
http://bit.ly/ptotype

Which ERP system is a good fit for medical products?
http://bit.ly/ERP-recos

Do you think there are too many FDA regulations?
http://bit.ly/FDA-rules

Device registration in a one country to cover every country?
http://bit.ly/one-for-all

++++++++++

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. If you do business in the Pacific, visit the http://AsiaPacificDeviceSummit.com site – it’s a new event and maybe the one you need.


Sid Goel
Founder at Heether Consulting Inc — Nurturing Innovations across the Value-chain (from Ideation seed to Valuable tree)!
CE marking, especially for Medical devices is one of the top regulatory requirements for Australia!

Donna Cusano
Builds Leadership Positions through Marketing + Communications | Healthcare + Tech | B2B/B2B2C | Editor & Writer
Spreading the word…[http://telecareaware.com/australias-med-device-fast-track-changes-webinar/|leo://plh/http%3A*3*3telecareaware%2Ecom*3australias-med-device-fast-track-changes-webinar*3/-mEL?_t=tracking_disc]

Arthur Brandwood
Medical devices and IVD regulatory expert with a global perspective
Today was the big day when the Australian government delivered on the first step of these reforms – enacting the regulatory change to lift the requirement for Australian domestic firms to submit to full TGA assessment. The locals now have access to the CE certificate route.

Donna Cusano
Builds Leadership Positions through Marketing + Communications | Healthcare + Tech | B2B/B2B2C | Editor & Writer
Thank you Arthur. I hope you don’t mind my spreading the word on Telehealth & Telecare Aware. We’re read primarily ex Australia (UK, US, EU) but OZ is within our top ten and our readership does have interest in Down Under.

Arthur Brandwood
Medical devices and IVD regulatory expert with a global perspective
Hi Mark

Indeed you are quite right that this was an effort of many. I would particularly like to acknowledge the efforts of the industry associations and especially AusBiotech and my colleagues on the regulatory expert panel of its medical devices division, Ausmedtech – who carried the torch on this for a long time.

Arthur

Arthur Brandwood
Medical devices and IVD regulatory expert with a global perspective
Hi Donna,

Indeed it does apply to all medical devices in Australia except for the very highest risk Class III with an integral medicine or a biologic – which require a direct TGA review.

Arthur (in transit in HK between China and Australia!)

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Not sure. I know Arthur is traveling. I’m sure he’ll comment when he can.

Donna Cusano
Builds Leadership Positions through Marketing + Communications | Healthcare + Tech | B2B/B2B2C | Editor & Writer
Does this apply to mobile health devices (e.g. telehealth, telecare)?

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Apologies if it read as though this was exclusively a Brandwood initiative.

As you note, he was heavily involved and I’m grateful he’s willing to share his knowledge with the group for free.

Thank you for the correction.

Mark Taffa
Owner, Horten Medical
Dear Joe,

These changes were “championed” by many companies and associations. Arthur Brandwood is well known and respected in the Australian industry and it is no surprise that he was heavily involved.

Your post implies a single person “championed” the change at the TGA which is not quite correct. These changes were at the top of the regulatory agenda for industry associations and other local manufacturers.

These changes are a fundamental regulatory shift for Australian manufacturers supplying our domestic market and very good news.

Mark

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